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Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational trial

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Trial Profile

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational trial

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Dec 2023

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At a glance

  • Drugs Semaglutide (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 19 Dec 2023 Results post hoc analysis included data from a subset of patients (N=251) with biopsy confirmed NASH and fibrosis stage F1-F3 ; comparing the evaluation of histological features of non-alcoholic steatohepatitis (NASH) between pathologists and a machine learning (ML) pathology model, published in the Hepatology
    • 14 Nov 2023 Results of post-hoc exploratory analysis of digital quantification of the collagen proportionate area (CPA) compared in the total biopsy area and non-steatotic liver tissue (fat-free CPA) following semaglutide treatment for NASH, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 24 Jun 2023 Data from 3 studies were taken from NCT03357380, NCT02970942 & NCT03987451 assessing the impact of T2D and other cardiometabolic parameters on weight loss presented at the European Association for the Study of the Liver Congress 2023.
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